{"recall":{"id":"fda-drug-99376","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA drug enforcement)","cat":"medicines","kids":false,"kind":"drug","title":"Chiesi USA, Inc. recalls CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0","firm":"Chiesi USA, Inc.","date":"2026-07-06","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.","code":"Lot #: 1239521, 1237454, Exp. Date 10/2027","quantity":"44280 vials","number":"D-0689-2026","classification":"Class II"}],"reason":"Lack of Assurance of Sterility","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Nationwide within the United States","nationwide":true,"states":[],"units":"44280 vials","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99376","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"392999e8b92fec79","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/drug/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99376","record":[{"status":"Ongoing","city":"Cary","state":"NC","country":"United States","classification":"Class II","openfda":{"application_number":["NDA022156"],"brand_name":["CLEVIPREX"],"generic_name":["CLEVIPIDINE"],"manufacturer_name":["Chiesi USA, Inc."],"product_ndc":["10122-610","10122-611"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"substance_name":["CLEVIDIPINE"],"rxcui":["1790239","1790242","1790245","1790246"],"spl_id":["e472cde4-d29e-44b2-b1ca-a6f4fcc01b1d"],"spl_set_id":["f9290625-b723-4eda-bab8-a97bef6041f6"],"package_ndc":["10122-611-01","10122-611-10","10122-610-01","10122-610-10"],"is_original_packager":[true],"nui":["N0000000069","N0000175421","M0006414"],"pharm_class_moa":["Calcium Channel Antagonists [MoA]"],"pharm_class_epc":["Dihydropyridine Calcium Channel Blocker [EPC]"],"pharm_class_cs":["Dihydropyridines [CS]"],"unii":["19O2GP3B7Q"]},"product_type":"Drugs","event_id":"99376","recalling_firm":"Chiesi USA, Inc.","address_1":"175 Regency Woods Pl Ste 600","address_2":"","postal_code":"27518-6007","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Nationwide within the United States","recall_number":"D-0689-2026","product_description":"CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.","product_quantity":"44280 vials","reason_for_recall":"Lack of Assurance of Sterility","recall_initiation_date":"20260706","center_classification_date":"20260714","report_date":"20260722","code_info":"Lot #: 1239521, 1237454, Exp. Date 10/2027","more_code_info":""}]}}